Devices and methods for therapeutic heat treatment

ABSTRACT

Devices and methods for providing therapeutic heating are disclosed herein. In one embodiment, the system includes a device body configured to provide heat to a portion of skin. The device body also includes a low-level heating region and a high-level heating area. The low-level heating region provides a continuous amount of heat at a first temperature, and the high-level heating area provides an intermittent amount of heat at a second temperature greater than the first temperature.

TECHNICAL FIELD

The present disclosure is directed generally to therapeutic heattreatment devices and methods combining continuous low temperatureheating or cooling with intermittent bursts of high temperature heating,and more specifically, therapeutic heat treatment devices and methodscombining continuous low temperature heating or cooling over a selectedregion with intermittent burst of high temperature heating provided atdiscrete locations within the low temperature heating region.

BACKGROUND

Heating or cooling devices are commonly used to relieve pain or to treatan injury. Applying a cold pack to an injured ankle, for example, canreduce the swelling in the joint from the injury. Applying heat can alsopromote the healing and pain relief of different areas of the body. Soremuscles and stiff joints are often treated with a heating pad toincrease blood flow and soothe discomfort. For example, many peopleapply heat to the lower back to relieve back pain. Heat can also be usedto provide relief from chronic painful conditions, such as fibromyalgia,rheumatism, arthritis and the like.

There are many existing methods and devices for heating various bodyparts. For example, electrical heating pads and blankets, disposablepads or patches that generate heat from chemical reactions, microwavablepillows, creams and lotions, water bottles, etc. are all used dependingon the body part and user preference. These devices and methodsgenerally provide constant and sustained heat to the affected body partto relax the muscles and associated joints. One drawback of many ofthese devices, however, is the inability to provide adjustable amountsof heat. Common heat treatment devices, for example, generally provide asingle heat level across the device with limited or no adjustabilitybetween low, medium and/or high levels of heat.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, the sizes and relative positions of elements in thedrawings are not necessarily drawn to scale. For example, the shapes ofvarious elements and angles are not drawn to scale, and some of theseelements are arbitrarily enlarged and positioned to improve drawinglegibility. Further, the particular shapes of the elements as drawn arenot intended to convey any information regarding the actual shape of theparticular elements, and have been solely selected for ease ofrecognition in the drawings.

FIG. 1A is an illustration of a mapping of thermal receptors of a humanleg and foot.

FIG. 1B is a graph of the excitation of thermal receptors versus appliedheat.

FIGS. 2A-3B are isometric views, FIGS. 4A and 4B are top views, and FIG.5 is an isometric view of heating wraps or pads configured in accordancewith embodiments of the disclosure.

FIG. 6A is an isometric view of a vest, FIG. 6B is an isometric view ofa seat cover and FIG. 6C is an isometric view of a brace, each of whichis configured in accordance with another embodiment of the disclosure.

FIG. 7A is an isometric view of a heating patch and FIG. 7B is a backview of a human form with a plurality of attached heating patchesconfigured in accordance with still another embodiment of thedisclosure.

FIG. 8 is an isometric view of a glove including a plurality of heatingpatches configured in accordance with another embodiment of thedisclosure.

FIG. 9 is a front and a back elevation view of a human wearing aportable system for treating of back pain including a plurality ofheating patches configured in accordance with another embodiment of thedisclosure.

FIG. 10 is a back elevation view of a human wearing a portable systemfor treating of back pain including a plurality of heating patchesconfigured in accordance with yet another embodiment of the disclosure.

FIG. 11 is a side elevation view of a human wearing a portable systemfor treating of knee pain including a plurality of heating patchesconfigured in accordance with yet another embodiment of the disclosure.

FIG. 12 is a schematic of variables controlled by the laboratory studydevice in accordance with another embodiment of the disclosure.

DETAILED DESCRIPTION A. Overview

Specific details of several embodiments of the disclosure are set forthin the following description and FIGS. 1A-12 to provide a thoroughunderstanding of these embodiments. A person skilled in the art willunderstand, however, that the disclosure may be practiced withoutseveral of these details or additional details can be added to thedisclosure. Moreover, several details describing well-known structuresor processes often associated with thermal treatment systems are notshown or described below in detail to avoid unnecessarily obscuring thedescription of the embodiments of the disclosure. In the Figures,identical reference numbers identify identical, or at least generallysimilar elements. To facilitate the discussion of any particularelement, the most significant digit or digits of any reference numberrefer to the Figure in which that element is first introduced. Forexample, element 210 is first introduced and discussed with reference toFIG. 2.

The present disclosure describes several embodiments of heating orcooling pain relief devices and methods and improvements over existingheating and cooling devices. In certain embodiments, for example, athermal treatment device is configured to apply a continuous amount oflow-level heat combined with discrete amounts or intermittent bursts ofhigh-level heat. As described below, the bursts of heat can be atdistinct locations within or around the areas producing the low levelheat. The low-level heat can be maintained as a constant application ofheat while the high-level heat is applied in intermittent bursts (e.g.,milliseconds in some embodiments).

To better appreciate the benefits of the combination of the continuouslow temperature heat and the intermittent high temperature heat, it ishelpful to understand the body's reaction to heat. The human body isgenerally sensitive to heat, with certain body parts having a highersensitivity than other body parts. The body's sensitivity to heat isrecognized by thermal receptors located in the skin and subcutaneoustissue. FIG. 1A illustrates a mapping of the thermal receptors 102 of ahuman leg 104 and foot 106. As shown in FIG. 1A, the receptors 102 havedefined receptive fields with little overlap between the fields. Thereceptors 102 are excited by heat that is applied to the skin. When thereceptors 102 become excited from the applied heat, they send signals tostimulate the brain. The brain can accordingly coordinate other bodilyfunctions in response to the signals sent from the receptors 102. Forexample, the brain can signal to the body to produce endorphins as ananalgesic response to the applied heat.

The thermal receptors located throughout the body can be excited oractivated at different temperatures. FIG. 1B, for example, is a graph108 of the excitation of various receptors versus applied heat. Thex-axis of FIG. 1 represents mechanical pressure in mN of excitedreceptors, and the y-axis represents the temperature in degrees C. ofthe applied heat. As illustrated by the graph 108, the majority of theexcitation of the thermal receptors occurs at temperatures above 42degrees C., although some excitation does occur at temperatures below 42degrees C. The excitation also generally peaks below 50 degrees C.Accordingly, in certain embodiments of the present disclosure, bursts ofheat in the range of 42-55 degrees C. are applied to discrete areas ofskin to excite the receptors. The thermal bursts may be applied incombination with low level heating (i.e., heating below the range of42-55 degrees C.). In other embodiments, however, the thermal bursts caninclude temperatures higher or lower than the range of 42-55 degrees C.For the purposes of this disclosure, thermal bursts can be defined asthe application of increased heat in discrete areas where thetemperature of the burst ranges from 0.1 to 25 degrees C. or more abovethe baseline temperature of the continuous low-level heat application.The thermal bursts can include a ramp up speed ranging from millisecondsto minutes to reach a maximum temperature. In addition and as describedbelow, the size of the area applying the thermal burst is generallyrelatively small in comparison to the area applying the low-level heat.

According to one embodiment of the disclosure, a method of applying heatto a living body applying a constant amount of heat to a first definedregion of the body at a first temperature. The method also includesapplying intermittent amounts of heat to a second defined region of thebody. The intermittent amounts of heat may be applied at a secondtemperature greater than the first temperature. According to furtherembodiments, the second region overlaps the first region. According tostill further embodiments, the intermittent amounts of heat aredelivered at pre-selected, focused points wherein the surface area ofthe second region is smaller than the surface area of the first region.

A method configured in accordance with another embodiment of thedisclosure includes a method of exciting thermal receptors in a livingorganism. The method includes heating a first portion of skin with agenerally constant amount of heat at a baseline temperature, and heatinga second portion of skin with a burst of heat at a temperature above thebaseline temperature while heating the first portion of skin with thegenerally constant amount of heat.

A device for providing therapeutic heat configured in accordance withstill another embodiment of the invention includes a device bodyconfigured to provide heat to a portion of skin. The body includes afirst low-level heating region for providing a continuous amount of heatat a first temperature. The body also includes a second high-levelheating region for providing an intermittent amount of heat (e.g., athermal burst) at a second temperature greater than the firsttemperature.

A device for providing therapeutic heat configured in accordance withstill another embodiment of the invention includes a device bodyconfigured to provide heat to a portion of skin. The body includes afirst heat-retaining region for capturing body heat and providing acontinuous amount of heat at a first temperature. The body also includesa second high-level heating region for providing an intermittent amountof heat (e.g., a thermal burst) at a second temperature greater than thefirst temperature. According to still further embodiments, theintermittent amounts of heat are delivered by heating pads less than 2″by 2″ is size.

B. Embodiments of Low-Level Heating and Cooling Combined withIntermittent High-Level Heating

FIGS. 2A-2C are isometric views of heating wraps or pads 202, 212 and222, respectively, illustrating various embodiments combining low-levelheating with intermittent amounts of high level heating configured inaccordance with several embodiments of the disclosure. One skilled inthe art will appreciate that devices configured to apply cooling canalso be combined with the intermittent high-level heat and besubstituted for any of the illustrated heating pads. In FIG. 2A, theheating pad 202 includes a body 204 having opposing end portions 205(identified individually as a first end portion 205 a and a second endportion 205 b) to facilitate attachment of the heating pad 202 to ahuman body. For example, the heating pad 202 can be used on a person'sback, arm, leg, etc. The end portions 205 can include various attachmentmechanisms, such as hook and loop closures, magnets, buckles, adhesives,etc. One skilled in the art will appreciate that the illustrated heatingpad 202 and body 204 are merely representative of one type of heatingpad and that the disclosure is not limited to the illustrated shapesand/or configurations in the Figures. For example, heating padsincluding features disclosed herein can include different shapes orconfigurations to accommodate different body parts or areas of the body.

The illustrated heating pad 202 also includes a power source 206operably coupled to a low-level heating region 208 having a generallyU-shaped configuration and a plurality of discrete high-level heatingareas 210. The power source 206 can include batteries, an electricalconnection to line power or any other suitable source of power. In theembodiment illustrated in FIG. 2A, the high-level heating areas 210 arearranged within a footprint of the low-level heating region 208.Alternatively, the high-level heating areas 210 can be arranged on anon-heated heat retaining substrate such that the heat from the humanbody is retained as the low-level heating regions. In still furtherembodiments, the high-level heating areas 210 can be individual heatingpads arranged independently on a human body. As described below,however, the high-level heating areas 210 can be dispersed in variousdifferent patterns and configurations. The low-level heating region 208is configured to provide a constant and baseline amount of heat toprovide pain relief. Each of the high-level heating areas 210 mayprovide discrete amounts of increased heat for a period of timesufficient to heat the skin or subcutaneous tissue to a desiredtemperature. For example, the high-level heating areas can apply burstsof heat ranging from 0.1 to 25 degrees C. or more above the baselinelow-level heating. In certain embodiments, the high level heating areas210 provide bursts of heat ranging from 42-55 degrees C.

The size of the individual high-level heating areas 210 is relativelysmall in comparison to the overall low-level heating region 208 or heatretaining substrate. For example, in certain embodiments, each of thehigh-level heating areas 210 may cover an area of 3 mm by 3 mm. In otherembodiments, these areas may be smaller (e.g., 1 mm by 1 mm) or larger(e.g, 40 mm by 40 mm), however, one skilled in the art will understandthat the high-level heating areas 210 may include a variety ofconfigurations and remain within the scope of this disclosure. Therelatively small area of the individual high-level heating areas 210 hasa low thermal mass that is capable of producing clear and rapidtemperature changes. For example, in certain embodiments the high-levelheating areas 210 can ramp up to the maximum high temperature inmilliseconds. In other embodiments, the ramp up time may be in the rangeof milliseconds to minutes, and the increased thermal burst can be heldfor a specified period of time (e.g., milliseconds, seconds, minutes,etc.). The relatively small size of the high-level heating areas 210also provides several benefits with reference to the power managementand conservation. The relatively smaller areas 210, for example, requireless power to reach the higher burst temperature.

The combination of the continuous low-level heating and intermittenthigh-level heating at discrete, focused regions provides severaladvantages over conventional heating systems. The augmentation of thecontinuous heating (or cooling), for example, provides enhanced painrelief by promoting blood flow, increasing flexibility and relaxingmuscles, ligaments and other tissues. The illustrated configurationachieves enhanced pain relief by providing a strong stimulation of thethermal receptors in the skin and subcutaneous tissues of the body byrapidly changing temperatures. The variations of the temperatures fromthe thermal bursts reduce or eliminate the accommodation of thereceptors to the stimuli. For example, when heat is applied to the bodyat a constant temperature, the receptors can accommodate the constantheat thus reducing the stimulation. The intermittent bursts of heat,however, can at least partially prevent the receptors from adjusting tothe heat by not providing sufficient time for accommodation. This isespecially effective when the intermittent bursts of heat are providedby heating pads of a relatively small surface area, for example 2″ by2″, or more particularly 1″ by 1″, or even more particularly, ½″ by ½″.This is unlike conventional heating systems that do not provide theability to disrupt the accommodation of the receptors. Accordingly, theintermittent focused bursts of heat, combined with the constant heat,provide for better receptor stimulation resulting in better analgesicresults.

The pattern and/or spatial relationship between the low-level heatingregion 208 and the high-level heating areas 210 can differ in variousembodiments according to different body parts and receptor stimulatingrequirements. In FIG. 2B, for example, the heating pad 212 includes thelow-level heating region 208 having a generally rectilinearconfiguration, and the each of the high-level heating areas 210 ispositioned outside of a footprint but proximate to a periphery of thelow-level heating region 208. Moreover, in the embodiment illustrated inFIG. 2C, the heating pad 222 includes separate first and secondlow-level heating regions 208 (identified individually as a first region208 a and a second region 208 b) each surrounded by a plurality ofhigh-level heating areas 210.

FIGS. 3A and 3B are isometric views of further embodiments of heatingwraps or pads 302 and 312, respectively, including different heatingpatterns and mechanisms to activate the heating areas. Turning first toFIG. 3A, the heating pad 302 includes the body 204 and the power source206, similar to the embodiments described above. In this embodiment,however, the high-level heating areas 310 of the heating pad 302 arepositioned around and between a plurality of discrete low-level heatingregions 308. Although the low-level heating regions 308 do not form asingle relatively large area to apply the continuous low-level heat, thetotal area of the low-level heating regions 308 may still besignificantly greater than the high-level heating areas 310. Moreover,in certain embodiments the low-level heating regions 308 can provideheat from a chemical reaction, and the high-level heating areas 310 maybe operably coupled to the power source 206 such that only thehigh-level heating areas 310 are electrically powered. In otherembodiments and as illustrated in FIG. 3B, a heating pad 312 may notinclude an electrical power source such that the heat from the low-levelheating regions 308 and the high-level heating areas 310 is created froma chemical source (e.g., a chemical reaction).

FIGS. 4A and 4B are top views of heating wraps or pads 402, 412,respectively, illustrating different configurations of continuouslow-level heating regions and high-level heating areas. The heating pad402 of FIG. 4A, for example, includes a plurality of discrete high-levelheating areas 410 that are generally dispersed in a low-level heatingregion 408 having a shape conforming generally to a body 404 of the wrap402. The illustrated low-level heating region 408 generally covers thearea of the body 404 between the high-level heating areas 410. As such,the total area of the high-level heating areas 410 is significantly lessthan the total area of the low-level heating region 408. FIG. 4Billustrates a heating pad 412 that is generally similar to the heatingpad 402 of FIG. 4A, except that in the illustrated embodiment theheating pad 412 includes a low-level heating region 418 that does notcover all of the area of the body 404 between each of the high-levelheating areas 410. Accordingly, the total area of the low-level heatingregion 418 may not be significantly greater than the total area of thehigh-level heating areas 410. For example, in certain embodiments thetotal area of the low-level heating region 418 may be equal to or lessthan the total area of the high-level heating areas 410. As a result,the illustrated heating pads 402, 412 and others disclosed herein can beconfigured to provide different relationships between the amounts ofheat delivered from the low-level region and the high-level areas.

In certain embodiments, the high-level heating areas described above canbe included as an add-on improvement to existing heating pads, wraps,etc. FIG. 5, for example, is an isometric view of a heating pad 502including a body 504 having a plurality of continuous low-level heatingregions 508. As will be appreciated, the low-level heating regions 508can be discrete areas or a single larger area as described above. Theheating pad 502 can include any commercially available heating wrap,pad, etc. In this embodiment, however, the heating pad 502 includes aplurality of high-level heating areas 510 coupled to the body 504 toprovide high temperature thermal bursts to supplement the continuouslow-level heating. More specifically, the high-level heating areas 510can be included in a film 509 that adheres or is otherwise attached tothe body 504. Similar to the embodiments described above, the heat fromthe high-level heating areas 510 can be provided from electrical,chemical or other sources. As such, the high-level heating areas 510 canbe added to the heating pad 502 and be positioned on or around thelow-level heating regions 508.

Although several of the embodiments described herein are associated withthermal wraps and pads, the novel intermittent focused thermal burstscombined with continuous low-level heating can be applied to numerousdifferent configurations and applications. FIGS. 6A-6C, for example,illustrate several embodiments of different products incorporating thesefeatures. FIG. 6A, more specifically, illustrates an article ofclothing, such as a vest 602, having a plurality of discrete high-levelheating areas 610. In certain embodiments, the entire vest 602 can beconfigured to provide continuous low-level heat to a person wearing thevest 602 such that the high-level heating areas 610 can supplement thecontinuous heat with thermal bursts of higher temperature heat. In otherembodiments, discrete portions of the vest 602 can provide thecontinuous low-level heating. Similar to the embodiments describedabove, the low and high-levels of heat can be provided from electricaland chemical sources, as well as a combination of these and/or othersources.

FIG. 6B is an isometric view of a chair 614 (e.g., car seat, officechair, etc.) with a seat cover 616 including a continuous low-levelheating region 618 combined with a plurality of discrete high-levelheating areas 620. The seat cover 616 can include an adapter 613 to drawelectrical power from a car or other source for either or both of thelow and high-level heating areas 618, 620. FIG. 6C is an isometric viewof a brace 628 for a body part (e.g., a knee, ankle, elbow, wrist, etc.)including a plurality of discrete high-level heating areas 630.Accordingly, the brace 628 can be configured to provide the therapeuticlow-level heat in combination with bursts of higher temperature heat.More specifically, the brace 628 can be configured to provide thehigh-level heating areas 630 at focused regions of much smaller surfacearea than the low level heating areas 618, thus requiring less power andyielding more efficacy in terms of pain relief.

FIG. 7A is an isometric view of a single heating patch 702 and FIG. 7Bis a back view of a human form 704 wearing a plurality of discreteheating patches 702 (e.g., at the shoulder, lower back, and hip). Theheating patches 702 may be configured to provide continuous low-levelheating with periodic bursts or impulses of high-level heat, similar tothe embodiments described above. In certain embodiments, the heatingpatches 702 include an adhesive to attach directly to the skin. As aresult, the heating patches 702 can be applied simultaneously to variousareas of the body and can be used in conjunction with one another orindependently to provide pain relief. The illustrated heating patches702 can accordingly accommodate users who suffer from pain in areaslocated in more than one region of the body thus requiring simultaneoustreatment. For example, the treatment of conditions such asfibromyalgia, dysmenorrhea, PMS, back and neck pain, sports relatedinjuries, etc. may greatly benefit from heating patches 702 located atdifferent positions to simultaneously treat one or more painful areas.FIG. 8 is an isometric view of a glove including a plurality of heatingpatches configured in accordance with yet another embodiment of thedisclosure.

Further configurations of the device, including those shown in FIGS.9-11 illustrate the versatility of the system. For example, FIG. 9includes heating pads 904 a-d, electrically connected by wire 906 to aportable power supply 902. The portable power supply 902 and the heatingpads 904 a-d are each carried by the user by a carrying device 910, 911such as a belt, pouch, harness or other carrying device. For ease ofuse, the power supply 902 can be rechargeable. In alternativeembodiments, the portable power supply is replaced by a power cordhaving a plug (not shown for purposes of clarity). In still furtherembodiments, the system 900 includes a remote control device 908. FIG.10 illustrates an alternative heating pad 904 a-d placement of thesystem of FIG. 9 and also eliminates the remote control carrying device911. FIG. 11 illustrates yet another embodiment of the system 900, whichis shown for use in relieving knee pain.

The embodiments described herein illustrate the versatility of thevarious and diverse applications of the high-level thermal burstsdelivered through small heating pads combined with low-level continuousheating. Although FIGS. 2A-11 illustrate specific embodiments ofproducts utilizing these heating combinations, the present disclosure isnot limited to the illustrated embodiments. Rather, the combinedintermittent high-level heating and continuous low-level heatingdescribed herein can be used with numerous different types of objects,devices, apparatuses, equipment, assemblies, appliance and the like,including both powered and non powered objects. For example, theintermittent high-level heating and continuous low-level heating can beused with, but are not limited to, pillows, travel pillows, varioustypes of clothing, shoes, ski boots, blankets, beds, mattresses,splints, lotions, ointments, rubs, salves, etc.

According to still further embodiments of the invention, the carryingdevice for the heating system can include garments or pockets ingarments to hold the heating pads. A separate garment can be designedspecifically to help treat dysmenorrhea by holding the heating pads tothe back and anterior abdomen or pelvis. Some of these garments may forexample include:

-   -   An elastic-like band to provide support to the underlying        tissues while combining the effects of pulsed heat.    -   Garments that include commercially available chemical or        microwavable heat packs. The garments support these products        while allowing the addition of the heating elements from the        disclosed device.    -   Garments that have the controller battery unit and healing        elements built in. This reduces bulk and the need to external        wires.    -   Heating elements that contain the battery, controller and        heating element packaged as one unit. The complete unit may        attach directly onto the user or to an element of clothing or        garment that supports the heater.

According to still further embodiments, the system can exist in at leastvarious configurations and versions, for example:

-   -   Boost. A version designed to improve or enhance the        effectiveness of chemical heating packs.    -   Sport. A version designed to for use with sport induced pain and        may include braces or other supportive garments.    -   Medical. A version designed to simultaneously treat multiple        sites on the body.

EXAMPLES

According to aspects disclosed herein, and further in accordance withthe Examples provided below, the combination of slow ramp up speeds,short bursts of heat, small pad sizes, and/or long soak periods not onlyproved effective in reducing pain but significantly reduced powerconsumption requirements and allowed use of small wires instead of thickcords.

In operation, the addition of as little as one degree centigradeincrease via the disclosed system to the steady state Thermacare® padproduced a 50% improvement in effect in pain relief. Without beinglimited by theory, it is believed that this improvement is due to thephenomena of accommodation of the thermal receptors to low level steadyheat. When accommodated, these receptors are balanced at the very edgeof stimulation. As further shown in the following examples, smallamounts of additional heat stimulate the receptors causing them to fireand thereby producing the very pleasant sensation of thermal comfort andpain relief.

The following Examples are for illustrative purposes only.

Example 1: Clinical Trial

Background

Chronic pain is a public health problem that affects many people in alllevels of our society. This study funded by the National Institutes ofHealth addresses the need for better non-pharmacological pain treatmentoptions. These methods include using pulsed heat alone and adding pulsedheat to improve the effectiveness of currently widely used treatments;FDA approved transcutaneous electrical nerve stimulators (TENS) andcommercial chemical heat pack (Thermacare, Proctor and Gamble). Advancesin thermal-based pain management technology may provide chronic painsuffers new options apart from drugs or procedures.

Heat produces analgesia through recognized physiologic mechanismsincluding stimulation of thermal receptors that inhibits nociception viathe gate-control theory, by increasing blood flow, and by reducingmuscular spasm. Similarly transcutaneous electrical nerve stimulators(TENS) reduce pain by electrically “blocking” pain impulses via gatingof nociception. Proof of concept study hypothesized that activation oftwo separate afferent “gating” pathways, c-fiber dependentthermo-receptor from heat and deep tissue large diameter A-beta primaryafferents from TENS would produce more analgesia than either heat orTENS used separately. Further hypothesized that heat alone would be aseffective as TENS alone in providing pain relief. Both hypotheses arestrongly supported.

Follow-Up Clinical Study:

A follow-up clinical trial was performed based on results of an initialproof of concept study. This clinical study used several laboratory testdevices created specifically for the clinical study. The study deviceswere controlled by a laptop computer connected to a central pug-in thatsupported a variable number of heating pads. The heating pads were ofvariable shapes and sizes. These study devices allowed the researcher toprecisely control and record a wide number of test variables. Thesevariables include:

-   -   Maximum, minimum, and duration of applied heat;    -   Characteristic of heat spike including shape of curve and        duration of spike;    -   Pattern of heat spikes and time heat is not applied (passive        cooling);    -   Ramp up and down time, t-soak temperature and t-soak time, T-max        time, heat cycle, demand cycle and lockout time (see figure        one).

The study was done with full Intuitional Review Board (IRB) approval. 30subjects were recruited from the community and included both those whosuffered from chronic pain and normal controls. All subjects underwenttesting over a single 90-120 minute period. The testing methods aredescribed below:

First Treatment Section

This section determined the participant's preference of heating padsize, temperature, and method of application.

-   -   1. Participant is shown three sizes of heating pads (small,        medium, large).    -   2. Each size pad is placed on subject's back or arm.    -   3. Temperature of heating pads is incrementally increased as the        participant is asked to rate how the temperature feels using        standardized comfort and thermal scales    -   4. Participant chooses a preferred temperature.    -   5. If participants suffers from chronic pain, he/she is asked to        rate their pain on a 0-10 scale.    -   6. Heat is applied, in random order, as a steady stimulus and        alternatively pulsed between skin temperature and the        participant's preferred temperature.    -   7. Participant selects a preferred pad size.    -   8. Participant selects a preferred heat application.    -   9. If participants suffers from chronic pain, he/she is asked to        rate their pain on a 0-10 scale.

More or Less Pain comfortable Scale if Time worn compared to ThermalBack 0 (terrible) Preferred comfortably Comfort Scale previous SensationPain Too hot for 10 (wonderful) Maximum Temperature Temperature (inseconds) Rating setting? Scale Present participant? scale Time 41/105.8120 Very comf warm No 8 2 Min 42/107.6 120 Comfortable same warm No 8 2Min 43/109.4 120 Comfortable same warm No 8 2 Min 43.5/110.3  120Comfortable same warm No 8 2 Min 44/111.2 120 Comfortable same warm No 82 Min X 44.5/112.1  120 Comfortable more warm No 8 2 Min 45/113  120Just Comf less hot No 7 2 Min 45.5/113.9  115 Just Comf less hot No 6 2Min 46/114.8 90 Just Uncom less hot No 4 2 Min 46.5/115.7  90 Just Uncomless hot No 4 2 Min 47/116.6 45 Just Uncom less hot No 4 2 Min47.5/117.5  2 Min 48/118.4 2 Min

Second Treatment Section

This section is used to determine the number of heating pads preferredby the participant.

-   -   1. 2 pads of preferred size are placed on participant and heated        to preferred temperature.    -   2. 4 pads of preferred size are placed on participant and heated        to preferred temperature.    -   3. 6 pads of preferred size are placed on participant and heated        to preferred temperature.    -   4. Participant selects preferred number of pads.    -   5. If participants suffers from chronic pain, he/she is asked to        rate their pain on a 0-10 scale.

Record participant's preference for number of pads. Time Start:    TimeEnd: 11:30 Number Preferred Comfort 0(terrible) to Preferred of tempfrom Scale 10(won- Maximum Number Pads Obj. #1 Rating derful) Time 2 2Min 4 44.5 comf. 7 2 Min 6 44.5 Very Comf. 8 2 Min X

Third Treatment Section

This section is used to help determine if significant variability intemperature preference exists between individuals.

-   -   1. Participants are reminded that the goal of the study is not        to determine who can bear the hottest temperature, but to        determine the range of temperature he/she finds comfortable.    -   2. Preferred pad size and number are placed on participant.    -   3. Temperature of pads is gradually increased.    -   4. Participant tells RA to stop when pads become uncomfortable        or a maximum of 49 degrees is reached.    -   5. If participants suffers from chronic pain, he/she is asked to        rate their pain on a 0-10 scale.

Objective #2: Best t-max and soak temperatures Note: Tmax spike duration2 seconds and Tsoak spike duration 2 seconds. Run each setting for 90seconds. Time Start:   Time End: Peak Low Peak Low Comfort T-max T-maxT-max Detect T-soak T-soak T-soak Scale 0(terrible) to Preferred settingsetting time Pulse? setting setting time Ratings 10(wonderful) 42 41 15seconds Yes/No 42 40 30 sec Comf 7 43 41 15 seconds Yes/No 42 40 30 secComf 7 43.5 40 15 seconds Yes/No 42 40 30 sec Comf 7 X 44 40 15 secondsYes/No 42 40 30 sec Comf 7 Comments: setting 1:                                          setting 2:                                          setting 3                                          setting 4:                                         

Fourth Treatment Section

This section is used to determine if subjects prefer steady or pulsedheat and if pulsed heat improves the effectiveness of continuous lowlevel heat.

-   -   1. Participants are fitted with a commercial chemical heat pack        (e.g., Thermacare®).    -   2. Measurements are taken in terms of the heat of the chemical        pad.    -   3. Comfort, thermal and pain ratings are taken after which the        participant is fitted with the study device using either 2 or        fours pads.    -   4. Temperature of heating pads is incrementally increased as the        participant is asked to rate how the temperature feels using        standardized comfort and thermal scales    -   5. Participant chooses a preferred temperature.    -   6. If participants suffers from chronic pain, he/she is asked to        rate their pain on a 0-10 scale.    -   7. Heat is applied, in random order, as a steady stimulus and        alternatively pulsed between skin temperature and the        participant's preferred temperature.    -   8. Participant selects a preferred pad size.    -   9. Participant selects a preferred heat application.    -   10. If participants suffers from chronic pain, he/she is asked        to rate their pain on a 0-10 scale.

Heating device used in conjunction with ThermaCare Note: Tmax spikeduration 2 seconds and Tsoak spike duration 2 seconds. Run each settingfor 90 seconds. Time Start:      Time End: Peak Low Estimated Comfort 0(terrible) Tmax Tmax Detect number of Peak/Low T- T-soak Scale to 10Preferred setting setting Tmax Time Pulse? pulses felt soak setting timeRatings (wonderful) 42 41 15 seconds Yes/No 42/40 30 sec Comf 8 X 43 4115 seconds Yes/No 42/40 30 sec Comf 8 43.5 40 15 seconds Yes/No 42/40 30sec Comf 7 44 40 15 seconds Yes/No 42/40 30 sec Comf 7 Comments:

Exit Interviews

After the entire session Exit Interviews were conducted to determineeffectiveness of each variation tested.

Results

The following table is a composite result of study subject (N=25subjects) comfort curves. Most participants found temperatures above 48degrees too hot. Most subjects preferred temperatures at 46 degrees orbelow. The median temperature for maximum comfort was 43 degrees abovewhich subjects reported less pleasant sensations. The maximumtemperature preferred by any subject (N=1) was 48 degrees. The minimumtemperature preferred by any subject was 41.5 degrees. No subjectpreferred 40 degrees. These findings have important implications forreduced power consumption and the need for individual controllability.The results also support that concept that for maximum effect subjectsshould be able to “tune” the temperature and thermal characteristics tomatch their thermodynamic profile. This profile is likely influenced byskin thickness, body fat, local blood flow, underlying pain and thethermal sensitivity of an individual's thermal receptors located in thedermal layers of the skin.

TABLE ONE Thermal and comfort results for 25 subjects. Temperature TimeComfort level   50 degrees C. <1 second Too hot 49.5 degrees C. <1second Too hot 49.0 <1 second Too hot 48.5 <1 second Too hot 48 15seconds Then too hot 47.5 36 seconds Then too hot 47 52 seconds Then toohot 46 120 seconds Never too hot

Results for Pad Size

The study determined that heating pad size less than ½ inch by ½ inchdid not result in pain relief. In fact the ½ inch pad size causedthermal burns without provoking the sensation of warmth. This is likelydue to the fact that the pad size was smaller than the ability of humansto detect temperature changes due to the corresponding size of thethermal receptive fields.

Pads 1 inch×1 inch produced the best results with the least amount ofenergy required to power the heating pads. Pads above 1 inch e.g., 1.5inch×1.5 inch also were effective at reducing pain but were notnecessarily more effective than the smaller pads and required moreelectrical power to function.

Pad Separation was Studied

1 inch×1 inch pads placed less than 6 inches apart wereindistinguishable from a single large pad placed across the entire back.At distances greater than 6 inches apart subjects were able todistinguish two separate pads. Without being bound by theory, this lackof discrimination was thought to be due to the size of the human thermalreceptive fields on the truncal surfaces. Receptive fields are muchsmaller on the face and hands. The use of the spatially separatedsmaller pads (less than 1.5 inches and greater than 0.5 inches) resultedin significant power savings.

Pad Separation Enhances the Effect of Proximal Heating Pads

1 inch×1 inch pads (pads A) placed on a body region (i.e. low back)produced pain relief and the sensation of comfort in the subjects. Asecond set of 1×1 pads (Pads B) placed on a separate body locationgreater than 12 inches from the treated body part (Pads A) caused thepain relief and sensation of comfort produced by Pads A to be greatlyenhanced. This finding of heating a distant non-painful body part toenhance the thermal analgesia of a separately treated body part hasimportant therapeutic implications. 75% of subjects who had a painfulbody part treated noted this beneficial effect.

Pulsed Heat Characteristics

The effectiveness and characteristics of heat pulses were studied.

-   -   The duration of the heat spike is important. Heat spike duration        is defined as the time required to reach t-max plus the duration        at T-max in seconds. No subject preferred a shorter heat spike        of 0.5 seconds. 10% of subjects preferred a heat spike duration        of 1 second. 90% of subjects preferred a heat spike that lasted        2 seconds.    -   The shorter the duration of the heat spike the hotter maximum        temperature is required to produce pain relief. Longer heat        spike duration results in lower required maximal temperatures to        produce a given state of comfort.    -   The ratio of peak to trough of the heat spike was important. A        separation of 2 degrees from peak to trough was detectable by        all subjects. Less than 2 degrees separation was not detectable        by subjects.    -   Subject comfort is determined by the peak of heating not by the        temperature of the trough.    -   100% of subjects preferred the temperature spikes over the        steady heat.    -   Subjects (100%) strongly preferred a pulsed soak cycle over a        steady no-pulsed soak cycle.    -   The addition of the soak cycle reduced power requirements        without reducing analgesic effectiveness.    -   The initial ramp up speed and ramp up time to the first T-max        was studied. 100% of subject reported an initial ramp up speed        of less than 15 seconds caused a “Burning sensation” that was        painful. Initial ramp times greater than 15 seconds did not        produce the painful sensation. In all cases the maximum        temperatures were the same. Ramp up times greater than 30        seconds also produced painful sensations. Therefore there is an        optimal window between 15 and 30 seconds that produces comfort.

Steady Low Level Heat Versus Pulsed Heat

All subjects reported that pulsed heat added to the Thermacare productproduced enhanced analgesia. There was a therapeutic window associatedwith this effect. The Thermacare product produced temperatures in therange around 40 degrees. The addition of as little as 1 degree oftemperature rise produced by the study device enhanced the effectivenessof the Thermacare product by 50%. This enhancement occurred over atemperature range of 1-2.5 degrees above which subjects reported noenhancement or even unpleasantness. This therapeutic window is thoughtto be produced by the thermal energy already added to the body by theThermacare product. Additional temperature added by the study deviceefficiently enhances analgesia but can quickly produce pain if thetherapeutic window is exceeded. This enhancement of analgesia by aslittle as one degree was produced only when the additional heat wasramped up over less than a 30 second period. Slower ramp up timesproduced a lesser effect likely due to the body's ability to accommodateto this additional heat. This finding has important implications fortreatment parameters and for energy efficiency.

Heat and Soak Cycle Results

As shown further in FIG. 12, once activated, the study device produced aseries of heating cycles. The heating cycle is composed of a ramp uptime, a t-max time, a ramp down time and a soak time. The ramp up time,a t-max time, and a ramp down time is called the active heat time. Theratio of the active heat time to the soak time was studied. A ratio of1:2 or even 1:3 was preferred by study subjects. That is a soak time oftwice or even three times the duration of the active heat time waspreferred and found effective. A typical effective active heating cyclelasted 15 seconds followed by a 30 second soak cycle. Increasing theratio by increasing the active heat time produced no enhancement ofanalgesia and was sometimes reported as unpleasant. This ratio has animportant effect on power consumption.

A number of heating cycles strung together is called a demand cycle. Theduration of the demand cycle was studied. A minimum demand cycle wasdetermined to be 120 seconds. Demand cycles longer than 300 secondsproduced incremental additional benefit. Demand cycles longer than 1000seconds produced little additional benefit.

Each demand cycle is followed by a lockout interval. During this periodsubjects could not activate a new demand cycle. The lockout intervalranged from 120-300 seconds. This reduced power consumption andincreased safety. 90% of subjects offered that the lockout intervalproduced a feeling of anticipation towards the next demand cycle therebyenhancing the effect of the study device and reducing the body's abilityto accommodate to the thermal analgesia.

-   -   1. The chemical heating packs delivered heat that was relatively        steady and once stable did not vary more than one degree from        the mean temperature. Participants clearly preferred heat that        was hotter than that provided by the chemical heating pack.    -   2. Heat added by the study device improved the effectiveness of        the heat supplied by the chemical heating pack as measured by        pain ratings, and thermal and comfort rating.    -   3. Pulsed heat as supplied by the heating device was preferred        by participants over both steady heat supplied by the chemical        pack and the study device.    -   4. Pulsed heat as supplied by the heating device improved the        effectiveness of the chemical heat device.    -   5. The participant's preferred heating range approximated a bell        shaped distribution that ranged from 41.5 degrees centigrade to        48 degrees centigrade.    -   6. The preferred temperature both t-max and soak temperatures        for any given participant was highly individualized and each        participant preferred that the heat applied was customized to        his or her individual preferences. This clearly increased the        effectiveness of the heat as compared to steady heat from the        chemical pack.    -   7. Customizable heat as delivered by the study device was        strongly preferred over steady state heat as delivered by the        chemical heating pads. This is felt due to the individual        characteristics of thermal heat receptors, skin characteristics,        and local blood flow.    -   8. Pulsed heat delivered during the cooling cycle (soak cycle)        was preferred to a cooling cycle with no pulsed heat.        Participants could easily differentiate pulsed from steady heat        both during the heating and soak cycles.    -   9. The placement of heating pads on a body part distant to the        part of the body with pain greatly improved the effectiveness of        the study device. For example if a participant had low back pain        adding heating pads to the neck or shoulder (non-painful area)        increased the effectiveness of the heating pads placed over the        painful area (low back).    -   10. The size of the heating pad was important. If the pad size        was too small the participant could not feel the heat. The pad        was likely too small to excite the participant's thermal        receptive field.

Example 2

Study Objectives

1. How hot (T-max) do the subjects want the heater? Estimated that itwill be in the neighborhood of 43-44 degrees. We do this by generating acomfort curve (steady heat) and by testing pulsed heat. Ask is subjecthas low back pain at present and to rate pain level on a 0-10 scale. Ifno back pain, no problem, just note that. We would like to determine ifthe comfort curves vary between subjects with no pain and subjects withpain.Place two pads on subject's low back. Use following treatment chart:

Thermal Comfort scale Duration of heat and Thermal sensation scalesTemperature stop at 2 minutes or stop if it becomes too hot 41 degreesUp to 2 minutes Comfort scale and tell us if/when it becomes too hot42   Up to 2 minutes Comfort scale and tell us if/when it becomes toohot 43 degrees Up to 2 minutes Comfort scale and tell us if/when itbecomes too hot. 44 degrees Up to 2 minutes Comfort scale and tell usif/when it becomes too hot 45 degrees Up to 2 minutes Comfort scale andtell us if/when it becomes too hot 45.5 degrees Up to 2 minutes Comfortscale and tell us if/when it becomes too hot. 46 degrees Up to 2 minutes46.5 Up to 2 minutes 47 degrees Up to 2 minutes 47.5 degrees Up to 2minutes 48 degrees Up to 2 minutes 48.5 degrees Up to 2 minutes 49degrees Up to 2 minutes 49.5 Up to 2 minutes 50 degrees Up to 2 minutesNote if subject indicates too hot at 45 degrees repeat heat at ½ degreelower2. What are the best tmax and soak temperatures? This study tries tonarrow the optimal temperature range of the heater. If subject doesn'tlike setting option to go higher.Tmax spike 2 seconds and T soak spike duration 2 seconds. First ramptime 15 seconds. Run time is 90 seconds per setting.

Rating Can they 0 (terrible) to detect 10 (wonderful) T max Tmax heat Tsoak T soak scale and settings time pulses? settings time comments 42.1peak 15 Yes/no 42/40 30 41low seconds seconds 43 peak 15 Yes/no 42/40 3041 low seconds seconds 43.5 peak 15 Yes/no 42/40 30 40 low secondsseconds 44 peak 15 Yes/no 42/40 30 40 low seconds seconds 44 peak 15Yes/no 40 low seconds3. Test with Thermacare® product. Do they like it? How hot does it needto be? Repeat study but first place Thermacare® wrap on subject. Wrapmust be opened at least 20 minutes prior to study.Tmax spike 2 seconds and T soak spike duration 2 seconds. Run time 60seconds per test.

Rating Can they 0 (terrible) to detect 10 (wonderful) T max Tmax heat Tsoak T soak scale and settings time pulses? settings time comments 41peak/ 15 Yes/no 42/40 30 40 low seconds seconds 42 peak 41 low 43 peak15 Yes/no 42/40 30 41 low seconds seconds 43.5 peak 15 Yes/no 42/40 3040 low seconds seconds 44 peak 15 Yes/no 42/40 30 40 low seconds seconds4. How many pads do subjects like? Use optimal setting from first trial.First place two pads then 4 pad then 6 pads. Ask subject to rate howmany pads they prefer. Measure distances between pads to determineability to discriminate.5. If time permits repeat study 2 over a different part of the bodyand/or neck. Do the comfort curves vary between parts of the body (lowback versus neck)? Effect of separating pads?

CONCLUSION

From the foregoing, it will be appreciated that specific embodiments ofthe disclosure have been described herein for purposes of illustration,but that various modifications may be made without deviating from thespirit and scope of the disclosure. For example, the high-level heatingareas may have other configurations or include more applications thanthose illustrated in the Figures. Moreover, specific elements of any ofthe foregoing embodiments can be combined or substituted for elements inother embodiments. Furthermore, while advantages associated with certainembodiments of the disclosure have been described in the context ofthese embodiments, other embodiments may also exhibit such advantages,and not all embodiments need necessarily exhibit such advantages to fallwithin the scope of the disclosure. Accordingly, embodiments of thedisclosure are not limited except as by the appended claims.

Where the context permits, singular or plural terms may also include theplural or singular term, respectively. In addition, unless the word “or”is expressly limited to mean only a single item exclusive from the otheritems in reference to a list of two or more items, the use of “or” insuch a list is to be interpreted as including (a) any single item in thelist, (b) all of the items in the list, or (c) any combination of theitems in the list. Furthermore, the term “comprising” is used throughoutto mean including at least the recited feature(s) such that any greaternumber of the same feature or additional types of features are notprecluded.

1-2. (canceled)
 3. A device for providing therapeutic heat, the devicecomprising: a device body configured to provide heat to a first portionof skin with at least one first heating element and to a second portionof skin with at least one second heating element; wherein the firstheating element applied to a low-level heating region provides acontinuous amount of heat at a first temperature; and wherein the secondheating element applied to high-level heating area provides anintermittent amount of heat at a second temperature greater than thefirst temperature.
 4. The device of claim 3 wherein the individualsecond heating element is generally round and less than approximatelytwo inches in diameter.
 5. The device of claim 3 wherein a plurality ofsecond heating elements are distributed over the living body.
 6. Thedevice of claim 3 wherein the first area of the body and the secondareas of the body are mutually exclusive.
 7. The device of claim 5wherein at least one of the plurality of the second areas at leastpartially overlaps with a portion of the first area.
 8. The device ofclaim 3 wherein the second heating element is proximate to the firstheating element.
 9. The device of claim 3 wherein the first areaincludes two or more discrete areas.
 10. The device of claim 3 wherein atotal area of the at least one first heating element in contact with thebody is equal to or less than a sum total area of the at least onesecond heating element in contact with the body.
 11. The device of claim3, wherein the second portion of skin comprises a plurality of discreteindividual second portions of skin, and wherein the first portion ofskin is substantially larger than individual second portions of skin.12. The device of claim 11 wherein a sum of the individual secondportions of skin is approximately equal in size to the first portion ofskin.
 13. The device of claim 11 wherein a sum of the individual secondportions of skin is larger than the first portion of skin.
 14. Thedevice of claim 3 wherein the second portion of skin comprises aplurality of discrete individual portions of skin.